Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Contact

Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Organization name
UDI-DI code
Reference / catalog number

Hyper-Box System, Sweden — Class IIa MDD by AOTI Limited

MD Atlas
AOTI Limited

EUDAMED last updated this device on Mar 27, 2026

Hyper-Box System, Sweden

B-05391518740881

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: AOTI Limited
UDI-DI code: 05391518740881
Reference / catalog number: G00001-2-SWE

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

Manufacturer information

Organization name: AOTI Limited
SRN: IE-MF-000025075
Manufacturer status: Active

Critical warnings

3 warnings recorded — scroll inside the panel to see all entries.

CW007
EUDAMED did not publish a description for this code.
CW010
EUDAMED did not publish a description for this code.
CW014
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Sweden; available across 1 country total.

Country	On market since	Until
SwedenPrimary placement		Still on market

Device identification

Trade name: Hyper-Box System, Sweden
UDI-DI code: 05391518740881
Basic UDI-DI: B-05391518740881
Reference / catalog number: G00001-2-SWE
Issuing entity: GS1

Classification

Risk category: Class IIa
Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Hyper-Box System configured for the Swedish market.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

A99DEVICES FOR ADMINISTRATION, WITHDRAWAL AND COLLECTION - OTHER

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Related devices

Hyper-Box System, AustriaB-05391518740980On the market Hyper-Box System, BelgiumB-05391518740997On the market Hyper-Box System, CyprusB-05391518741499On the market Hyper-Box System, DenmarkB-05391518740973On the market Hyper-Box System, FinlandB-05391518740690On the market

Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.